MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 LM - 9MM

Model Number 02.18.IF2.09.LM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Muscular Rigidity (1968)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 30 november 2020 lot 168001: 24 items manufactured and released on 24-jan-2017.Expiration date: 2021-12-18.No anomalies found related to the problem.To date, 12 items of the same lot have been already sold without any other similar reported event.

Event Description

The patient came in reporting tightness in the knee.The surgeon performed a synectomy and revised the medacta tibial insert fix s2 lm - 9mm with a medacta tibial insert fix s2 lm - 8mm 5 months after primary.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S2 LM - 9MM
• Type of Device: TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 11030205
• MDR Text Key: 222268143
• Report Number: 3005180920-2020-00929
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 07630030895876
• UDI-Public: 07630030895876
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K162084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2021
• Device Model Number: 02.18.IF2.09.LM
• Device Catalogue Number: 02.18.IF2.09.LM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention